Under the cover of transfusion medicine hides the reality of blood safety and efficacy in clinical practice. The recent publication of the journalist Douglas Starr on blood is an epic in history of medicine and commerce which clearly describes the urgent need for regulatory frame works to protect public from unnecessary damage due to lack of standards and quality management in blood supply.
Blood transfusion services are a vital part of the National Health Services. The exponential advancement in the field of transfusion medicine has brought into focus blood transfusion safety and regulatory requirement. A comprehensive legislation to ensure quality control on collection, testing, storage, distribution and infusion of blood and blood components was formulated by the Drug Controller General of India (DCGI) [1]. The Director General of Health Services (Ministry of Health and Family Welfare) carries out amendments from time to time relating to blood transfusion services in the Drugs and Cosmetics Act, 1940 and Rules thereunder to meet the latest requirements for blood safety.
The problems of transfusion associated acquired immuno deficiency syndrome resulted in a notification in 1989 under the Drugs and Cosmetics Act which made the test for HIV mandatory. The Drugs and Cosmetic Rules were again amended (Rules 68A, Part X B and Part XII B of Schedule F) in the year 1992-93 and the DCGI was vested with the power of Central Licence Approving Authority (CLAA) to approve the licence of notified drugs viz blood and blood products, IV fluids, vaccines and sera [1].
Human blood is covered under the definition of “Drugs” under Section 2(b) of Drugs and Cosmetics Act. Hence it is imperative that the blood banks need to be regulated under the Drugs and Cosmetics Acts and Rules thereunder and the licence is granted for operating a blood bank by the State and Central Licencing Approving Authorities after inspection (1).
The Drugs and Cosmetics Rules 1945 was published as required by sections 12 and 13 of Drugs and Cosmetics Act, 1940 (23 of 1940). Drugs and Cosmetics (1 st Amendment) Rules, 1992 was published on 22 Jan 1993 vide GSR 28(E) [2]. Seeing the dismal state of blood banks a writ petition titled “Common Cause Vs Union of India” was filed in the Supreme Court of India in the year 1992. In a landmark judgement Supreme Court passed the following ruling:
All blood banks to be licensed within 2 years. Eliminate professional donors within 2 years. Steps for starting special post-graduate courses (MD) in Transfusion Medicine be initiated.The 1 st Amendment dated 22 January 1993 [2] related to collection, storage, processing and distribution of whole blood, blood components by blood banks and licensing of all blood banks being made mandatory – Sec 18(c)
Total area of 150 sq m shall be provided for blood banks (100 sqm) with additional 50 sq m for preparation of blood components. It shall consist of the following rooms: